Proposed Information Collection Activity; Comment Request, 6198-6199 [2014-02175]
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Federal Register / Vol. 79, No. 22 / Monday, February 3, 2014 / Notices
portal; to manually enter data within the
web portal itself; or to submit .xml files
containing their information. Once the
states and issuers submit their data, they
will receive an email notifying them of
any errors, and that their submission
was received.
CMS is mandating the issuers verify
and update their information on a
quarterly basis and is requesting that
States verify State-submitted
information on an annual basis. In the
event that an issuer enhances its
existing plans, proposes new plans, or
deactivates plans, the organization
would be required to update the
information in the web portal. Changes
occurring during the three month
quarterly periods will be allowed
utilizing effective dates for both the
plans and rates associated with the
plans.
Form Number: CMS–10320 (OMB#:
0938–1086); Frequency: Reporting—
Annually/Quarterly; Affected Public:
health insurance issuers in the
individual and small group markets;
Number of Respondents: 801; Total
Annual Responses: 3,051; Total Annual
Hours: 27,833. (For policy questions
regarding this collection contact Kim
Heckstall at 410 786 1647.)
Dated: January 28, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–02124 Filed 1–31–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: ADP & Services Conditions for
FFP for ACF.
OMB No.: 0970–0417.
Description: State child support
agencies are required to establish and
operate a federally approved statewide
automated data processing and
information retrieval system to assist in
child support enforcement. States are
required to submit an initial advance
automated data processing planning
document (APD) containing information
to assist the Secretary of the Department
of Health and Human Services in
determining if the state computerized
support enforcement system meets
federal requirements and providing
federal approval. States are also
required to submit annually an updated
APD for oversight purposes. Based on
assessment of the information provided
in the initial or updated APDs, states
that do not meet federal requirement
approval will need to complete an
independent verification and validation.
The Advance Planning Document
(APD) process, established in the rules
at 45 CFR Part 95, Subpart F, is the
procedure by which States request and
obtain approval for Federal financial
participation in their cost of acquiring
Automatic Data Processing (ADP)
equipment and services. State agencies
that submit APD requests provide the
Department of Health and Human
Services (HHS) with the following
information necessary to determine the
States’ needs to acquire the requested
ADP equipment and/or services:
(1) A statement of need;
(2) A requirements analysis and
feasibility study;
(3) A procurement plan;
(4) A proposed activity schedule; and,
(5) A proposed budget.
The proposed information collection,
is authorized by (1) 42 U.S.C. 654A,
which provides a state agency to have
a single statewide automated data
processing and information retrieval
system and sets forth the requirements
of that system; (2) 42 U.S.C. 654(16),
which provides the state must submit an
initial, and annually updated, advance
automated data processing planning
document for project approval; (3) 45
CFR 307.15, which provides the
requirements for approval of advance
planning documents; (4) 42 U.S.C.
652(d), which provides the Secretary
with the authority to approve an APD
and to assess the computerized support
enforcement system status; 45 CFR
95.626, which determines when an
Independent Verification and Validation
must be completed.
HHS’ determination of a State
Agency’s need to acquire requested ADP
equipment or services is authorized at
sections 602(a(5)), 652(a)(1), 1396(a)(4)
and 1302 of United States Code.
Respondents: States.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
mstockstill on DSK4VPTVN1PROD with NOTICES
RFP and Contract ............................................................................................
Emergency Funding Request ..........................................................................
Biennial Reports ..............................................................................................
Advance Planning Document ..........................................................................
Operational Advance Planning Document .......................................................
Independent Verification and Validation (ongoing) .........................................
Independent Verification and Validation (semiannually) .................................
Independent Verification and Validation (quarterly) ........................................
System Certification .........................................................................................
Estimated Total Annual Burden
Hours: 6,414.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
VerDate Mar<15>2010
20:46 Jan 31, 2014
Jkt 232001
4
5
54
34
20
3
1
1
1
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1.5
.1
1
1.2
1
4
2
4
1
Average
burden hours
per response
4
2
1.50
120
30
10
16
30
240
Total burden
hours
324
1
81
4,896
600
120
32
120
240
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
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03FEN1
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Federal Register / Vol. 79, No. 22 / Monday, February 3, 2014 / Notices
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–02175 Filed 1–31–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0078]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Drug User
Fee Act Cover Sheet
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the paperwork burden of animal drug
sponsors to fill out the Animal Drug
User Fee Act (ADUFA) cover sheet.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by April 4, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
DATES:
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Animal Drug User Fee Cover Sheet—
(OMB Control Number 0910–0539)—
Extension
Under section 740 of the FD&C Act
(21 U.S.C. 379j-12), as amended by
ADUFA (Pub. L. 108–130), FDA has the
authority to assess and collect for
certain animal drug user fees. Because
the submission of user fees concurrently
with applications and supplements is
required, review of an application
cannot begin until the fee is submitted.
The types of fees that require a cover
sheet are certain animal drug
application fees and certain
supplemental animal drug application
fees. The ADUFA cover sheet (Form
FDA 3546) is designed to provide the
minimum necessary information to
determine whether a fee is required for
the review of an application or
supplement, to determine the amount of
the fee required, and to assure that each
animal drug user fee payment and each
animal drug application for which
payment is made is appropriately linked
to the payment that is made. The form,
when completed electronically, will
result in the generation of a unique
payment identification number used in
tracking the payment. FDA will use the
information collected to initiate
administrative screening of new animal
drug applications and supplements to
determine if payment has been received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA Form No.
740(a)(1) .......................
mstockstill on DSK4VPTVN1PROD with NOTICES
FD&C Act section
amended by ADUFA
3546 (Cover Sheet) ....
1There
Number of
respondents
17
Number of responses
per respondent
Total annual
responses
1 time for each application.
17
Average
burden per
response
Total hours
1
17
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents to this collection of
information are new animal drug
applicants or manufacturers. Based on
FDA’s database system, there are an
estimated 173 manufacturers of
products or sponsors of new animal
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20:46 Jan 31, 2014
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drugs potentially subject to ADUFA.
However, not all manufacturers or
sponsors will have any submissions in
a given year and some may have
multiple submissions. The total number
of annual responses is based on the
PO 00000
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Fmt 4703
Sfmt 4703
average number of submissions received
by FDA in fiscal years 2011–13. The
estimated hours per response are based
on past FDA experience with the
various submissions. The hours per
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]]>Agencies
[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Notices]
[Pages 6198-6199]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02175]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: ADP & Services Conditions for FFP for ACF.
OMB No.: 0970-0417.
Description: State child support agencies are required to establish
and operate a federally approved statewide automated data processing
and information retrieval system to assist in child support
enforcement. States are required to submit an initial advance automated
data processing planning document (APD) containing information to
assist the Secretary of the Department of Health and Human Services in
determining if the state computerized support enforcement system meets
federal requirements and providing federal approval. States are also
required to submit annually an updated APD for oversight purposes.
Based on assessment of the information provided in the initial or
updated APDs, states that do not meet federal requirement approval will
need to complete an independent verification and validation.
The Advance Planning Document (APD) process, established in the
rules at 45 CFR Part 95, Subpart F, is the procedure by which States
request and obtain approval for Federal financial participation in
their cost of acquiring Automatic Data Processing (ADP) equipment and
services. State agencies that submit APD requests provide the
Department of Health and Human Services (HHS) with the following
information necessary to determine the States' needs to acquire the
requested ADP equipment and/or services:
(1) A statement of need;
(2) A requirements analysis and feasibility study;
(3) A procurement plan;
(4) A proposed activity schedule; and,
(5) A proposed budget.
The proposed information collection, is authorized by (1) 42 U.S.C.
654A, which provides a state agency to have a single statewide
automated data processing and information retrieval system and sets
forth the requirements of that system; (2) 42 U.S.C. 654(16), which
provides the state must submit an initial, and annually updated,
advance automated data processing planning document for project
approval; (3) 45 CFR 307.15, which provides the requirements for
approval of advance planning documents; (4) 42 U.S.C. 652(d), which
provides the Secretary with the authority to approve an APD and to
assess the computerized support enforcement system status; 45 CFR
95.626, which determines when an Independent Verification and
Validation must be completed.
HHS' determination of a State Agency's need to acquire requested
ADP equipment or services is authorized at sections 602(a(5)),
652(a)(1), 1396(a)(4) and 1302 of United States Code.
Respondents: States.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
RFP and Contract................................ 4 1.5 4 324
Emergency Funding Request....................... 5 .1 2 1
Biennial Reports................................ 54 1 1.50 81
Advance Planning Document....................... 34 1.2 120 4,896
Operational Advance Planning Document........... 20 1 30 600
Independent Verification and Validation 3 4 10 120
(ongoing)......................................
Independent Verification and Validation 1 2 16 32
(semiannually).................................
Independent Verification and Validation 1 4 30 120
(quarterly)....................................
System Certification............................ 1 1 240 240
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 6,414.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation, 370 L'Enfant Promenade SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the
[[Page 6199]]
proposed collection of information; (c) the quality, utility, and
clarity of the information to be collected; and (d) ways to minimize
the burden of the collection of information on respondents, including
through the use of automated collection techniques or other forms of
information technology. Consideration will be given to comments and
suggestions submitted within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014-02175 Filed 1-31-14; 8:45 am]
BILLING CODE 4184-01-P
